Breast cancer

Impasse over ‘chemo sparing’ tumour profiling tests for early breast cancer


Regulatory barriers mean that Australian women with breast cancer must pay $5000 to access ‘chemo sparing’  tumour profiling tests that are reimbursed as standard of care in other countries, a Parliamentary inquiry has been told.

While tests such as Oncotype DX and MammaPrint are recommended and subsidised in many other developed countries, they have been repeatedly rejected for reimbursement in Australia by the Medicare Services Advisory Committee, according to industry sponsors speaking at the public hearing for the “Approval processes for new drugs and novel medical technologies in Australia”.

The recurrence score tests are recommended by agencies such as NICE in the UK based on evidence from trial such as TAILORx that they can identify patients who will not benefit from also receiving adjuvant chemotherapy, thus sparing them the adverse effects and other risks associated with chemotherapy.

However, Carlo Montagner, CEO of Specialised Therapeutics Australia, told the inquiry that his company had made six unsuccessful applications to have Oncotype DX made available on Medicare, but had been kept in the dark about the reasons for their continual rejection.

“All six applications have been strongly supported by local breast cancer specialists, surgeons, medical oncologists and Australia’s breast cancer patient advocacy group, BCNA. The last time we were rejected, we didn’t even receive an explanation until I submitted an FOI request,” he said.

“The minutes we eventually received stated that MSAC wanted evidence from a different type of trial. The breast cancer experts we’ve spoken to since have said that the sort of trial that MSAC is requesting would be unethical to conduct in Australia, and it would take at least a decade to produce those results.”

“The documents we did receive under FOI were so heavily redacted that we remain completely in the dark, even today, as to the real reasoning behind this really strange request for a trial that no oncologist would recruit patients to.”

Mr Montagner said Australia had become “the laughing-stock of the world” over the delays in reimbursement for recommended oncology tests and treatments.

“If you’re a citizen in 20 or 30 other countries in the world—thousands of women can avoid chemotherapy. But, if you’re an Australian citizen, unfortunately, unless you have $5,000 in the bank or you can borrow money, you miss out on this test.”

The FOI documents show that MSAC rejected the sixth application for the Oncotype DX gene expression profiling for 21 genes  in women with newly diagnosed stage I or II breast cancer, who are ER-positive or progesterone receptor positive, HER2-negative, and lymph node negative (LN-negative), in 2020.

The MSAC consideration noted that the tumour profiling test was given a strong recommendation in ASCO guidelines, and it had been recommended for public funding since 2013 in the UK and other countries such as Canada for use in early-stage ER+, HER2–, node-negative invasive breast cancer patients with ‘intermediate risk’.

The rationale for its rejection was not made public.

Mr Montagner said he would like to see a meeting with oncologists and breast cancer surgeons talking to government to resolve the situation, and in particular the lack of transparency.

“I would ask the minister to convene an expert panel—we have world-class experts in our backyard here — to work with MSAC and resolve why they continue to take this position, which defies global and local consensus around the routine use of this test,” he said.

MSAC has also rejected reimbursement for another tumour profiling test, the 70-gene signature MammaPrint, which has also been shown to identify breast cancer patients for whom adjuvant chemotherapy (CT) could be safely omitted.

According to Cancer Australia, the rejection was based on MSACs interpretation of the MINDACT trial, which it said showed that overall breast cancer outcomes were poorer in women who did not have chemotherapy based on the MammaPrint test, compared with those who received chemotherapy.

The latest long term results from the MINDACT trial have just been published in Lancet Oncology. The investigators concluded that that the trial: “shows excellent survival for women with high clinical risk and low genomic risk treated without chemotherapy at five years, a timeframe considered for chemotherapy cytotoxic benefit.”

“Similarly to TAILORx, the updated results of MINDACT indicate that relying on the genomic signature to forego adjuvant chemotherapy is safer in older women with a high clinical risk than in younger women.”

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